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Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the EC  has approved Rixathon® (biosimilar rituximab*) for use in Europe**. Rixathon is approved for use in all indications of the reference medicine, MabThera® [2],[3]. 

Numerate, Inc., a computational drug design company applying artificial intelligence (AI) at cloud scale to transform small molecule drug discovery, announced the formation of a multi-year agreement with Takeda Pharmaceutical Company Limited under which Numerate will identify and deliver multiple clinical candidates.

Eisai Co Ltd announced that it has entered into a new joint research agreement with the Broad Institute , a collaborative research institute which includes researchers from the Massachusetts Institute of Technology and Harvard University to develop a new antimalarial medicine based on antimalarial drug targets the team identified last year.

goBalto, Inc., the leading provider of cloud-based clinical study startup (SSU) solutions, announced its partnership with Citeline, part of Informa's Pharma Intelligence vertical, to integrate data from Citeline's intelligence platforms — including Trialtrove and Sitetrove — with goBalto's Select.

Astellas Pharma Inc and Pfizer Inc announced the amendment of the protocol for the registrational PROSPER trial, a multi-national, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of XTANDI in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC).

HedgePath Pharmaceuticals, Inc , a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer.

Acasti Pharma Inc announced the achievement of a major corporate milestone by manufacturing the first cGMP batches of CaPre®, Acasti’s omega-3 pharmaceutical product candidate, produced with a proprietary and innovative continuous manufacturing process developed in partnership with CordenPharma.

Sartorius Stedim Biotech (SSB), a leading international supplier to the biopharmaceutical industry announced an agreement with Nova Biomedical (Nova), a well-known US manufacturer of cell culture analyzers, to integrate their BioProfile® FLEX2 into the ambr® multi-parallel bioreactor systems for automated, at-line cell culture analytics.

Contract development and manufacturing organisation (CDMO) Saneca Pharma has been granted a multiple dosage form approval for the manufacture and supply of solids, semi-solids and liquid finish dose products to Russia.

Manufacturers with high volume and high speed production lines rely on their coding and marking system’s availability to keep production lines running.

Bosch has launched a new pilot fermenter for the cultivation of active pharmaceutical ingredients (APIs) on laboratory and pilot scale. “In the pharmaceutical industry, the manufacture of complex compounds using biotechnological methods continues to grow in importance.

New industry research reveals that more than one third (36 per cent) of pharmaceutical manufacturers and contract packagers are not currently preparing for global serialization requirements, despite impending deadlines. 

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  • Q1 2017 sales rise by 25 percent to EUR 2.4 billion
  • EBITDA pre exceptionals increases by 25 percent to EUR 328 million

Eurofins Scientific , a world leader in biopharmaceutical testing, announces the acquisition of Alphora Research Inc , a full service contract research, development and manufacturing organization (CRDMO) for complex and niche small molecule active pharmaceutical ingredients (APIs), based in Mississauga, Ontario, Canada.    

TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced financial and company results for the first quarter of 2017. 

The deadlines for serialisation compliance in the EU and the U.S. are drawing closer. For many pharmaceutical companies, the journey towards implementing a full serialisation solution is well underway, but for others the complexity of the task means that there is still a lot to do. 

At the discovery and early stages of drug development, the aim is to evaluate the pharmacology, pharmacokinetics and toxicology of a compound using a simple liquid formulation.

The last decade has seen an increased emphasis on research and development into personalized medicines, including cell, gene and immunotherapy treatments 

Juniper Pharma Services , a subsidiary of Juniper Pharmaceuticals, Inc. , has broadened its manufacturing capabilities bringing on-line its new spray dryer following the successful installation and validation of the advanced manufacturing equipment at its UK-based site.

Compounded Sodium Bicarbonate PF 8.4% 50mEq per syringe is expected to help alleviate chronic drug shortage impacting the nation’s hospitals.

Greenphire, the global leader in clinical trial payment automation, has established an Advisory Group for the growing CRO community. The goal of this group is to empower CROs to play a more active role in shaping the rapidly evolving payment automation market.